REFERENCE CODE GDHC225DFR PUBLICAT ION DAT E JULY 2013 FORXIGA (TYPE 2 DIABETES) - FORECAST AND MARKET ANALYSIS TO 2022

Transcription

1 REFERENCE CODE GDHC225DFR PUBLICAT ION DAT E JULY 2013 FORXIGA (TYPE 2 DIABETES) -

2 Executive Summary Below table provides a summary of Forxiga for Type 2 diabetes in the 10 major pharmaceutical markets during the forecast period from Forxiga (dapagliflozin): Key Metrics in 10 Major Pharmaceutical Markets 2012 Market Sales US $0m 5EU $0m Japan $0m China $0m India $0m Brazil $0m Total $0m Key Events ( ) BMS/Astrazeneca s Forxiga launch in US (2014), 5EU (2013) and Japan (2014) 2022 Market Sales Level of Impact US $473m 5EU $327m Japan $27m China $663m India $107m Brazil $80m Total Source: GlobalData. 5EU: France, Germany, Italy, Spain, UK. $1.7bn Sales for Forxiga in the Global Type 2 Diabetes Market Global drug sales for Forxiga are forecast to increase from $0 million in 2012 to $1.7 billion in 2022 at a Compound Annual Growth Rate (CAGR) of 13.81%. The major drivers of Forxiga sales growth in the Type 2 Diabetes therapeutics market will include: Blood Pressure lowering ability Insulin independent effects in compare to other drug class Absence of Hypoglycemia causing characteristic Availabilty of product in oral dosage form The major hurdles for Forxiga sales of the Type 2 Diabetes therapeutics market will include: Severe side effects such as breast and bladder cancer, genital and urinary tract infections and dehydration 2

3 Executive Summary The below figure illustrates the sales of Forxiga for Type 2 Diabetes therapeutics in the 10 major markets during the forecast period. Sales of Forxiga by Region, % 6.38% 4.77% 1.61% 2022 Total: $1.7bn 19.50% 28.21% US 5EU Japan China India Brazil Source: GlobalData. What Do the Physicians Think? I think that [the number of] people needing a second and third drug is going to increase dramatically in the next 10 years and that we will just see those numbers go up, up, up. Two things are going to drive that up. One is the expectation that we ll treat these people fairly aggressively to get their A1c down to around 7 to 7.5. The target appears to be moving based on a few of the studies, but we are not going to tolerate people after 8.5 and 9 like we used to. That s going to drive it, and second is that most people are not going to have a control over lifestyle, they are going to continue to overeat and under-exercise and they are going to see their weight continue to go up and therefore their need for more medications will go up with it. So I think [in this] the market, the sky is the limit on how much the market is going to be. I think over the next 10 years the long-acting GLP- 1 receptor agonist therapies will increase the most, because now you know the companies will be developing once-a-week treatments Longeracting preparations, if they are proved to be effective and safe, will be used more and more because they really do have a benefit in weight loss. 3

4 Executive Summary Weight change direction or level and the risk of hypoglycemia, these are strong determinants for the choice of the drug today or in the future even more. My biggest challenge [with type 2 diabetes] has been the lack of long-term efficacy; that the disease is complicated, the disease is resilient, and most of the agents are not potent enough to get everybody under control long enough. So, lack of efficacy and having therefore to combine medications has been my biggest challenge. We have SGLT-2 inhibitors, we have the longacting GLP-1 receptor agonists, DPP-4 inhibitors, and this will be quite a choice now for physicians to find the right drugs or right combination of drugs. The SGLT-2s and the dual PPARs are probably going to have a better impact long-term the things that increase insulin secretion, somewhat are similar to the sulfonylureas, they are going to have hypoglycemic events, or they are going to cause people to gain weight, or they are going to burn the pancreas out I am much less impressed with them than I am with the SGLT-2s and the dual PPARs. The whole concept of individualization of therapy is very important; it is something that we practiced for a long time. Each patient is different. We have to give quite a combination of drugs to each patient depending on various factors. I think the use of metformin [first-line therapy] will not change. I think it will continue, but the use of sulfonylureas will decline I think they will be gradually replaced by newer therapies, some available now, some will be available later in the future. 4

5 Executive Summary The endocrinologist recognized that being overly conservative can hurt the patients, so in other words if you say that there is no long-term data for new drug that can prevent complications, you can t wait. I am not going to wait for 10 years for randomized controlled trials to show me that injection will dispel. If I know that it prevents complications, I am happy. We are not going to have 300 randomized controlled trials checking all possible combinations because now it s so many combinations of drugs you could test. So, me and other colleagues, what we have been doing really for years is that we know what works and we know what doesn t work we know that we don t have data but we really need to prescribe certain therapies without data, knowing what the advantages are. I think that the newer guidelines fully acknowledge the reality, that s what endocrinologists are doing, I think the guidelines didn t set up anything new, they are just catching up with what physicians are doing already. 5

6 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Prognosis Quality of Life Symptoms Disease Management Treatment Overview Diagnosis and Referrals Treatment Guidelines Competitive Assessment Overview Strategic Competitor Assessment

7 Table of Contents 6 Forxiga (dapagliflozin) Overview Efficacy Safety SWOT Analysis Forecast Appendix Bibliography Abbreviations Methodology Forecasting Methodology Diagnosed Type 2 Patients Percent Drug-Treated Patients Drugs Included in Each Therapeutic Class Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Generic Erosion Physicians and Specialists Included in this Study About the Authors Analyst II CVMD Therapy Director CVMD and Infectious Disease Global Head of Healthcare

8 Table of Contents 7.7 About GlobalData Disclaimer List of Tables Table 1: Symptoms of Type 2 Diabetes Table 2: Diagnostic Tests and Typical Criteria for Type 2 Diabetes Table 3: Treatment Guidelines for Type 2 Diabetes Table 4: Most-Prescribed Drugs (Following Metformin and Sulfonylureas) for Type 2 Diabetes by Class in the Global Markets, Table 5: Leading Branded Treatments for Type 2 Diabetes, Table 6: Product Profile Forxiga Table 7: Forxiga SWOT Analysis, Table 8: Global Sales Forecasts ($m) for Forxiga, Table 9: Key Launch Dates Table 10: Key Patent Expiries Table 11: Number of High-Prescribing Physicians Surveyed List of Figures Figure 1: ADA/EASD General Recommendations for Antihyperglycemic Therapy

9 Introduction 2 Introduction 2.1 Catalyst The American Diabetes Association s 73 rd Scientific Sessions, held in June 2013, represented an opportunity for the major industry players with a stake in the type 2 diabetes market to showcase their diabetes drugs latest results. In particular, Eli Lilly presented new data on its investigational drugs, dulaglutide and empagliflozin, as well as confirmed its development and regulatory timescale for biosimilar insulin products, including a version of Sanofi's Lantus. Another key takeaway from the ADA sessions was Sanofi s encouraging data on its Lantus follow-on product, aimed at protecting its Lantus franchise. While the global type 2 diabetes markets is crowded with inexpensive generics and marked by a pipeline filled with me-too drugs, GlobalData expects this market to undergo substantial growth between 2012 and 2022, more than doubling over this period. The main driver of this enormous expansion will be the dramatic increase in disease prevalence, which is attributable to increased life expectancy and an increasingly sedentary and stressful lifestyle. The second largest driver will be the physicians efforts to delay disease progression and reduce the costly burden of diabetic complications through the use of combination therapies and novel branded drugs. In the emerging markets in particular, uptake of branded drugs will increase due to rapid economic growth. Despite the high number of marketed therapies, this market is still experiencing large unmet needs and it has a significant growth opportunity for new patent-protected products. Metformin will remain the first-line therapy for type 2 diabetes due to physicians familiarity with it and the availability of long-term data, but the usage of sulfonylureas, another front-line therapy, will gradually be replaced over the next 10 years by novel therapies with improved side-effect profiles. The battle for secondor third-line therapy will involve DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors and other upcoming novel therapies. Of all currently marketed classes, GLP-1 receptor agonists will experience the fastest growth due to their weight-loss effects and the skyrocketing epidemic of obesity. With the recent therapeutic guidelines putting emphasis on a patient-tailored approach in treating type 2 diabetes, pharmaceutical companies will achieve considerable success with their me-too drugs. In the future, companies may choose to focus not on blockbuster medicines, but rather on niche drugs that are aimed at smaller groups. 9

10 Introduction 2.2 Related Reports GlobalData (2013). Actos (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC214DFR GlobalData (2013). Byetta (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC215DFR GlobalData (2013). Victoza (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC216DFR GlobalData (2013). Bydureon (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC217DFR GlobalData (2013). Lyxumia (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC219DFR GlobalData (2013). Januvia (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC220DFR GlobalData (2013). Onglyza (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC221DFR GlobalData (2013). Tradjenta (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC222DFR GlobalData (2013). Galvus (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC223DFR GlobalData (2013). Nesina (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC224DFR GlobalData (2013). Invokana (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC226DFR 10

11 Introduction GlobalData (2013). Humalog (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC227DFR GlobalData (2013). Lantus (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC228DFR GlobalData (2013). Levemir (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC229DFR GlobalData (2013). Novolog (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC230DFR GlobalData (2013). Apidra (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC231DFR GlobalData (2013). Tresiba (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC232DFR GlobalData (2013). Albiglutide (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC233DFR GlobalData (2013). Dulaglutide (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC234DFR GlobalData (2013). Semaglutide (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC235DFR GlobalData (2013). Trelagliptin (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC236DFR GlobalData (2013). MK-3102 (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC237DFR GlobalData (2013). Empagiflozin (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC238DFR GlobalData (2013). Tofogliflozin (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC239DFR 11

12 Introduction GlobalData (2013). Ipragliflozin (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC240DFR GlobalData (2013). Fasiglifam (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC241DFR GlobalData (2013). LY (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC242DFR GlobalData (2013). LY (Type 2 Diabetes) Forecast and Market Analysis to 2022, July, 2013, GDHC243DFR+ GlobalData (2013). Type 2 Diabetes United States Drug Forecast and Market Analysis to GDHC133CFR. GlobalData (2013). Type 2 Diabetes France Drug Forecast and Market Analysis to GDHC134CFR. GlobalData (2013). Type 2 Diabetes Germany Drug Forecast and Market Analysis to GDHC135CFR. GlobalData (2013). Type 2 Diabetes Italy Drug Forecast and Market Analysis to GDHC136CFR. GlobalData (2013). Type 2 Diabetes Spain Drug Forecast and Market Analysis to GDHC137CFR. GlobalData (2013). Type 2 Diabetes United Kingdom Drug Forecast and Market Analysis to GDHC138CFR. GlobalData (2013). Type 2 Diabetes Japan Drug Forecast and Market Analysis to GDHC139CFR. GlobalData (2013). Type 2 Diabetes China Drug Forecast and Market Analysis to GDHC140CFR. GlobalData (2013). Type 2 Diabetes India Drug Forecast and Market Analysis to GDHC141CFR. 12

13 Introduction GlobalData (2013). Type 2 Diabetes Brazil Drug Forecast and Market Analysis to GDHC142CFR. GlobalData (2013). Type 2 Diabetes Current and Future Players. GDHC1018FPR. 13

14 Appendix 7.7 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore. 7.8 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 47